Long Term Vascular Changes in Type 1 Diabetes (DM09)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
University Hospital, Aker
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00991575
First received: October 7, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted

October 7, 2009
October 7, 2009
April 2009
April 2010   (final data collection date for primary outcome measure)
Fatal and non fatal cardiovascular disease (CVD) and stroke [ Time Frame: One year ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Vessel area stenosis [ Time Frame: One year ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Long Term Vascular Changes in Type 1 Diabetes
Long Term Vascular Changes in Type 1 Diabetes, Clinical Aspects and Biological Markers

The main purpose of this study is to investigate progression of late complications of diabetes during the last ten years in a well characterized cohort of type 1 diabetes with a long duration of the disease, and to define factors responsible for the progression of late complications.

Despite intensively research in the field of hyperglycaemia and coronary heart disease in type 1 diabetes it is still not known in detail how hyperglycaemia leads to damage of the vessels.

The aims of the present proposal are therefore two-fold:

  1. To study in detail the progression of atherosclerosis (and micro vascular complications) in a well characterized cohort of type 1 diabetes with a long duration of the disease. This project will be a continuation of the Oslo study, a cohort started in 1982, with the last follow-up study in 1999/2000.
  2. To define factors responsible for the progression of coronary heart disease (and micro vascular complications) in this cohort.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

whole blood, serum, white cells, urine, tissue

Probability Sample

This project will be a continuation of the previous cohort performed originally from 1982. The group or cohorts will be selected from primary care clinic.

  • Diabetes Mellitus, Type 1
  • Complications
  • Coronary Heart Disease
Not Provided
Diabetes, type 1
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
45
May 2010
April 2010   (final data collection date for primary outcome measure)

The original criteria from 1982:

Inclusion Criteria:

  • Age 18-45 years
  • Diagnosis of type 1 diabetes at < 30 years of age, disease duration > 7 but < 30 years
  • C-peptide < 0, 1 nmol/l

Exclusion Criteria:

  • Serum creatinine > 150 µmol/l
  • Diastolic blood pressure <100mmHg
  • Overt nephropathy
  • Proliferative retinopathy
  • Pregnancy
  • A history of neuropathy
  • Other chronical disease
  • Treatment with other drugs except insulin and oral contraceptives
Both
40 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00991575
916501, S-08843c/21262
Yes
Kristian F. Hanssen, Professor MD, Oslo University hospital
Oslo University Hospital
University Hospital, Aker
Principal Investigator: Kristian F Hanssen, Professor MD Oslo university hospital, Aker, Norway
Oslo University Hospital
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP